AstraZeneca Trial Finds No Survival Benefit for New Lung Therapy

AstraZeneca said on December 22, 2025 that LATIFY, a global, randomized Phase III trial testing the ATR kinase inhibitor ceralasertib together with the PD L1 immunotherapy Imfinzi failed to meet its primary endpoint of improved overall survival compared with standard of care docetaxel. The study enrolled 594 adults with locally advanced or metastatic non small cell lung cancer whose disease had progressed after prior anti PD L1 therapy and platinum based chemotherapy.

The trial, registered as D533BC00001 and NCT05450692, began on September 15, 2022 and listed primary completion on October 6, 2025. Recruitment was complete and the registry showed an estimated study completion date of October 30, 2026 with verification of the record on November 1, 2025. LATIFY was an open label, multi centre study that randomized patients one to one to receive either ceralasertib plus Imfinzi or docetaxel. The investigational arm administered ceralasertib at 240 milligrams orally twice daily for seven days in each 28 day cycle, with a fixed 1,500 milligram infusion of Imfinzi on day eight. The control arm received docetaxel every three weeks.

AstraZeneca said the combination did not produce a statistically significant improvement in overall survival versus docetaxel. Company statements and trial records characterized the outcome as not meeting the primary endpoint. Reporting from the study noted that the combination was generally well tolerated and that no new safety signals were identified during the trial.

Ceralasertib is an ATR inhibitor that targets a key protein in the DNA damage response, a mechanism intended to sensitize tumors and modify the immune environment when paired with PD L1 blockade. AstraZeneca referenced prior Phase II data from the HUDSON study that had shown promising efficacy for the ceralasertib and Imfinzi combination in a similar population. The Phase III result will force a reassessment of that signal in a larger, randomized setting.

The setback has implications for patients and for AstraZeneca's broader oncology strategy. The company has placed ceralasertib within a wider push to expand its cancer portfolio as it pursues ambitious revenue goals through the end of the decade. With LATIFY not meeting its primary survival goal, decisions on further development, potential subgroup analyses, and regulatory plans will be closely watched by clinicians and investors.

Susan Galbraith, Executive Vice President, Oncology Haematology R and D at AstraZeneca, said the goal of LATIFY was to "reinvigorate the immune response of patients with lung cancer whose tumours stopped responding to available therapies by combining ATR inhibition with immunotherapy," and noted the company was disappointed by the result while remaining committed to developing new medicines to improve outcomes in lung cancer.

AstraZeneca has indicated that detailed LATIFY results and trial summaries are posted on its clinical trial pages. Clinicians will be seeking full survival statistics, subgroup analyses, and adverse event breakdowns to understand whether any subpopulations might still benefit from the combination.